BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 9281166 · Received November 5, 2019

    Report

    Report Number
    2210968-2019-89450
    Event Type
    Injury
    Date Received
    November 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? ==>I DO NOT BELIEVE THE PRODUCT WAS DEFECTIVE. I DO NOT FEEL THE PRODUCT ITSELF CAUSED THE COMPLICATION.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1007/S10029-019-02026-3; PUBLISHED ONLINE 30AUG2019. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ABDOMINAL WALL RECONSTRUCTION WITH LARGE POLYPROPYLENE MESH: IS BIGGER BETTER? THIS RETROSPECTIVE STUDY EVALUATES CLINICAL AND ECONOMIC OUTCOMES FOLLOWING ABDOMINAL WALL RECONSTRUCTION (AWR) WITH COMPONENT SEPARATION UTILIZING MULTIPLE MESHES AND LARGE POLYPROPYLENE MESH (LM) UP TO 50 X 50 CM. THE PATIENTS UNDERWENT REPAIR WITH EITHER A SINGLE LARGE POLPYPROPYLENE MESH OR MULTIPLE MESHES SUTURED TOGETHER UTILIZING A RUNNING NO. 1 POLYPROPYLENE SUTURE. BETWEEN 01AUG2013 AND 15FEB2018, 20 PATIENTS (MALE=10, FEMALE=10; MEAN AGE=55 YEARS; BMI= 32 KG/M^2) UNDERWENT AWR WITH LARGE PROLENE SOFT POLYPROPYLENE 50 X 50 CM MESH (ETHICON). REPORTED COMPLICATIONS INCLUDED INFECTED SEROMA (N=5%), DEEP WOUND INFECTION (N=5%). IN CONCLUSION, THE ANALYSIS OF HERNIAS WITH LOSS OF DOMAIN REPAIRED WITH A LARGE 50 CM × 50 CM POLYPROPYLENE MESH. COMPARED TO HERNIA REPAIRS WITH MULTIPLE MESH PIECES, THERE IS NO DIFFERENCE IN 30-DAY OUTCOMES OR COSTS. LONG-TERM ANALYSES ARE REQUIRED TO ASSESS THE CLINICAL AND ECONOMIC VALUE THAT MAY BE PROVIDED BY PERFORMING COMPLEX ABDOMINAL WALL RECONSTRUCTION WITH A SINGLE LARGE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074251 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention